September 18, 2019

Frederick A. Stearns

Frederick Stearns' practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics.

Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). He also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions.

Mr. Stearns is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, and dietary supplements.

Articles in the National Law Review database by Frederick A. Stearns

LATEST LEGAL NEWS & ANALYSIS

TRENDING LEGAL ANALYSIS

Upcoming Legal Education Events

Wednesday, September 18, 2019
Tuesday, September 24, 2019
Thursday, September 26, 2019
Thursday, October 17, 2019
Wednesday, October 23, 2019
Wednesday, November 6, 2019
Wednesday, November 13, 2019
Wednesday, December 11, 2019